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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 022460

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NDA 022460 describes JALYN, which is a drug marketed by Waylis Therap and is included in one NDA. Additional details are available on the JALYN profile page.

The generic ingredient in JALYN is dutasteride; tamsulosin hydrochloride. There are eighteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the dutasteride; tamsulosin hydrochloride profile page.

Summary for 022460

Tradename:	JALYN
Applicant:	Waylis Therap
Ingredient:	dutasteride; tamsulosin hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.5MG;0.4MG
Approval Date:	Jun 14, 2010	TE:	AB	RLD:	Yes

Expired US Patents for NDA 022460

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	JALYN	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	022460-001	Jun 14, 2010	5,565,467	⤷ Get Started Free
Waylis Therap	JALYN	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	022460-001	Jun 14, 2010	5,998,427	⤷ Get Started Free
Waylis Therap	JALYN	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	022460-001	Jun 14, 2010	5,846,976	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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